CRED ERP 25

01/07/2025

Timing to submit a generic or biosimilar MA application

Reference product is protected in two ways bearing in mind the statement that the generic product requirements should be ‘ without prejudice to the law relating to the protection of industrial and commercial property ’ and ‘ ensuring that innovative firms are not placed at a disadvantage ’

1. Patent (including supplementary protection certificates)

2. Data exclusivity

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Patents

Patent Protection • Patents granted to the innovator on the molecule/formulation/process /indication to protect commercialisation of the product by someone else prior to patent expiry • refers to an exclusive right to prevent others from exploiting an invention without the patentee’s consent Supplementary Protection Certificate (SPC) • Supplementary protection certificates were introduced to compensate for the long time needed to obtain regulatory approval of medicinal products • Offset the loss of patent protection

• Applied in individual MS • Up to 5yrs exclusivity

Neither are taken into consideration by Regulatory Authorities regarding assessment

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